Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-31 @ 3:54 AM
Study NCT ID:
NCT01386333
Status:
COMPLETED
Last Update Posted:
2013-11-04
First Post:
2011-06-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of Intranasal Oxytocin in Frontotemporal Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057180', 'term': 'Frontotemporal Dementia'}, {'id': 'D020774', 'term': 'Pick Disease of the Brain'}], 'ancestors': [{'id': 'D057174', 'term': 'Frontotemporal Lobar Degeneration'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010121', 'term': 'Oxytocin'}], 'ancestors': [{'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'lastUpdateSubmitDate': '2013-11-01', 'studyFirstSubmitDate': '2011-06-29', 'studyFirstSubmitQcDate': '2011-06-30', 'lastUpdatePostDateStruct': {'date': '2013-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': '2 week', 'description': 'Safety and Tolerability of 24 international units (IU), 48 IU and 72 IU of intranasal oxytocin administered twice daily for 1 week to patients with Frontotemporal Dementia as assessed by the number of participants with adverse events. Adverse events will be assessed by a standardized questionnaire and serum sodium levels will be monitored.'}], 'secondaryOutcomes': [{'measure': 'Neuropsychiatric Inventory', 'timeFrame': '1 week', 'description': 'Behavioural ratings at baseline and 1 week of oxytocin treatment compared to 1 week of placebo treatment'}, {'measure': 'Frontal Behavioural Inventory', 'timeFrame': '1 week'}, {'measure': 'Clinicians Global Impression of Change', 'timeFrame': '1 week'}, {'measure': 'Clinical Dementia Rating- Frontotemporal Lobar Degeneration', 'timeFrame': '1 week'}, {'measure': 'Interpersonal Reactivity Index', 'timeFrame': '1 week'}, {'measure': 'Multi-faceted Empathy Test', 'timeFrame': '1 week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Frontotemporal Dementia', 'oxytocin', "Pick's disease"], 'conditions': ['Frontotemporal Dementia']}, 'referencesModule': {'references': [{'pmid': '25503617', 'type': 'DERIVED', 'citation': 'Finger EC, MacKinley J, Blair M, Oliver LD, Jesso S, Tartaglia MC, Borrie M, Wells J, Dziobek I, Pasternak S, Mitchell DG, Rankin K, Kertesz A, Boxer A. Oxytocin for frontotemporal dementia: a randomized dose-finding study of safety and tolerability. Neurology. 2015 Jan 13;84(2):174-81. doi: 10.1212/WNL.0000000000001133. Epub 2014 Dec 10.'}]}, 'descriptionModule': {'briefSummary': 'Oxytocin is a hormone produced by the brain that appears to have important roles in social cognition and emotion in humans. In a pilot study, the effects of a single dose of oxytocin on measures of emotion recognition and behaviour in patients with Frontotemporal Dementia were investigated. The results from the pilot study suggested that oxytocin may be associated with a modest improvement in neuropsychiatric behaviours seen in patients with Frontotemporal Dementia. To further examine the safety and tolerability of oxytocin in this disorder, the present study will examine the safety and tolerability of three different doses of intranasal oxytocin administered to patients with Frontotemporal Dementia twice daily for 1 week.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 30-80 years\n* Meets "Neary criteria" for diagnosis of probable frontotemporal dementia\n* Neuroimaging (CT, MRI or SPECT scan) supports diagnosis of frontotemporal dementia\n* Provides written informed consent and has a caregiver or legally acceptable representative who provides written informed consent.\n\nExclusion Criteria:\n\n* Has a history of a myocardial infarction within the last two years or congestive heart failure.\n* Current uncontrolled hypertension\n* Current bradycardia (rate \\< 50 beats per minute/bpm) or tachycardia (rate \\> 100 bpm)\n* Current hyponatremia\n* Current use of prostaglandin medications\n* Females who are pregnant or breastfeeding\n* Use of any investigational or experimental drug or device within the last 60 days prior to screening or within 5 half-lives of the experimental drug , whichever is longer.'}, 'identificationModule': {'nctId': 'NCT01386333', 'acronym': 'FTDOXY10EF', 'briefTitle': 'Safety Study of Intranasal Oxytocin in Frontotemporal Dementia', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'A Phase I Dose Finding Study of Intranasal Oxytocin in Frontotemporal Dementia, Protocol # FTDOXY10EF', 'orgStudyIdInfo': {'id': 'R-11-232'}, 'secondaryIdInfos': [{'id': '17783', 'type': 'OTHER', 'domain': 'REB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oxytocin 24IU', 'description': 'Oxytocin 24 IU administered intranasally twice daily for 1 week', 'interventionNames': ['Drug: oxytocin']}, {'type': 'EXPERIMENTAL', 'label': 'Oxytocin 48 IU', 'description': '48 IU of intranasal oxytocin administered twice daily for 1 week', 'interventionNames': ['Drug: oxytocin']}, {'type': 'EXPERIMENTAL', 'label': '72 IU oxytocin', 'description': '72 IU of intranasal oxytocin administered twice daily for 1 week', 'interventionNames': ['Drug: oxytocin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline nasal spray', 'interventionNames': ['Drug: oxytocin', 'Drug: Saline Nasal Mist']}], 'interventions': [{'name': 'oxytocin', 'type': 'DRUG', 'description': 'Patients will be randomized to receive intranasal oxytocin or placebo in a dose escalation paradigm with three dose cohorts: 24IU, 48IU and 72IU of intranasal oxytocin twice daily for 1 week', 'armGroupLabels': ['72 IU oxytocin', 'Oxytocin 24IU', 'Oxytocin 48 IU', 'Saline nasal spray']}, {'name': 'Saline Nasal Mist', 'type': 'DRUG', 'description': 'Placebo arm wil receive saline nasal mist sprays matched in number to oxytocin dose cohorts', 'armGroupLabels': ['Saline nasal spray']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A 4V2', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Cognitive Neurology and Alzheimer Research Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Elizabeth C Finger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Western Ontario, Lawson Health Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'collaborators': [{'name': 'Consortium of Canadian Centres for Clinical Cognitive Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cognitive Neurologist', 'investigatorFullName': 'Elizabeth Finger', 'investigatorAffiliation': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}}}}